ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Acetaminophen 500mg | Pain reliever |
| Diphenhydramine HCl 25mg | Nighttime Sleep aid |
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur with this product if you take
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while you are using this product
Do not use
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- with other products containing acetaminophen (prescription or nonprescription).
Ask a doctor before use if you have
- liver cirrhosis
- asthma
- breathing problems such as emphysema or chronic bronchitis
- trouble in urinating due to an enlargement of the prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery.
Stop use and ask a doctor if
These could be signs of a serious condition.
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years of age and over: | take 2 caplets at bedtime or as directed by a doctordo not take more than 2 caplets in a 24 hour period |
| children under 12 years or age: | do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage |
- do not take more than recommended (see overdose warning)
Other information
- store at 20°-25°C (68°-77°F)
- see end panel for lot number and expiration
- each tablet contains: magnesium 0.05 mg
Inactive ingredients
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide
SPL UNCLASSIFIED SECTION
Distributed By: J.P Business Enterprise Lake Grove, NY 11755